Overview The principal objective of the Biostatistics and Data Management Core Facility is to provide a full collaborative scientific core for research design, conduct, data management and data analysis support for the program projects and cores. That includes preparation of codebooks, assignment of ID numbers, integration of data from different sources, responsibility for data quality assurance and the maintenance of clinical trial databases and preparing data quality control reports. Dr. Qaqish will be responsible for managing the day-today activities of the Core, and tracking the use of Core resources. He will be the lead statistician in the Core, with contributions from Dr. Kosorok in the area of personalized medicine treatment regimes. Dr. Qaqish and Dr. Kosorok will provide advice on statistical issues that arise in the design and analysis of studies and experiments in the program projects as well as in the other supporting cores. They will also participate in preparing manuscripts, reports and presentations. Project-specific Statistical Considerations Project I Data analysis will involve fitting linear and non-linear regression models, analysis of variance and analysis of covariance. Project II presents a systematic approach to linking in vitro data from human cell culture systems to the human clinical experience (Project III) via in vivo animal models.